吡咯替尼或来那替尼联合卡培他滨治疗HER-2阳性晚期乳腺癌疗效及安全性的Meta分析  

Meta-analysis of the efficacy and safety of Pyrotinib or Neratinib combined with Capecitabine in the treatment of HER-2 positive advanced breast cancer

作　　者：姜菁华 王岩 马庆功 王薇 章龙珍 JIANG Jinghua;WANG Yan;MA Qinggong;WANG Wei;ZHANG Longzhen(Xuzhou Medical University,Jiangsu Xuzhou 221000,China;Department of Radiation Oncology,Affiliated Hospital of Xuzhou Medical University,Jiangsu Xuzhou 221000,China)

机构地区：[1]徐州医科大学,江苏徐州221000 [2]徐州医科大学附属医院肿瘤放疗科,江苏徐州221000

出　　处：《现代肿瘤医学》2022年第17期3115-3120,共6页Journal of Modern Oncology

基　　金：江苏省研究生科研与实践创新计划项目(编号:KYCX20_2491)。

摘　　要：目的:比较吡咯替尼或来那替尼联合卡培他滨(Pyrotinib/Neratinib+Capecitabine,P/N+C)与拉帕替尼联合卡培他滨(Lapatinib+Capecitabine,L+C)治疗HER-2阳性晚期乳腺癌的疗效性及安全性。方法:检索PubM ed、Web of Science、Embase和Cochrane图书馆数据库,选自2005年01月01日截至2021年02月20日的潜在临床研究,合格的研究是前瞻性和注册的临床试验。对无病进展期(progression-free survival,PFS)、客观缓解率(objective response rate,ORR)及疾病控制率(disease control rate,DCR)具有95%置信区间(confidence interval,CI)的合并优势比和治疗相关不良事件的合并风险比进行Meta分析。结果:本次Meta分析包括3项随机对照试验,共有1015例患者被纳入本研究。在P/N+C组,6个月PFS[OR=1.87,95%CI(1.44,2.43),P<0.00001]、12个月PFS[OR=3.87,95%CI(1.95,7.70),P=0.0001]及ORR[OR=1.70,95%CI(1.10,2.64),P=0.02]较L+C组延长;在常见的治疗相关的不良事件中,除P/N+C组的腹泻发生率较L+C组高[RR=3.10,95%CI(1.80,5.35),P<0.0001]以外,其余治疗相关不良事件均无显著差异。结论:本Meta分析表明,使用吡咯替尼或来那替尼联合卡培他滨治疗HER-2阳性晚期乳腺癌的疗效更好,并且是一种安全的治疗选择。Objective:To compare the efficacy and safety of Pyrotinib/Neratinib combined Capecitabine(P/N+C)and Lapatinib plus Capecitabine(L+C)in the treatment of HER-2 positive advanced breast cancer.Methods:The following databases PubMed,Web of Science,Embase and Cochrane Library were searched online,which were selected from the potential clinical studies from January 1,2005 to February 20,2021.Eligible studies were prospective and registered clinical trials.The combined odds ratio with 95%confidence interval(CI)of progression-free survival(PFS),objective response rate(ORR),disease control rate(DCR)and the combined risk ratio of treatment-related adverse events were Meta-analyzed.Results:This Meta-analysis included 3 randomized controlled trials,and a total of 1015 patients were included in this study.In P/N+C group,there was significant difference in 6 months FPS[OR=1.87,95%CI(1.44,2.43),P<0.00001]and 12 months PFS[OR=3.87,95%CI(1.95,7.70),P=0.0001]and ORR[OR=1.70,95%CI(1.10,2.64),P=0.02]compared with L+C group.Among the common treatment-related adverse events,except that the incidence of diarrhea in P/N+C group was higher than that in L+C group[RR=3.10,95%CI(1.80,5.35),P<0.0001],there was no significant difference in other treatment-related adverse events.Conclusion:This is the latest Meta-analysis of the regimen.The results indicate that the treatment of Pyrotinib or Neratinib plus capecitabine is a better treatment for HER-2 positive advanced breast cancer and is a safe treatment option.

关 键 词：吡咯替尼/来那替尼(P/N) 拉帕替尼(L) 卡培他滨(C) HER-2阳性乳腺癌 META分析 

分 类 号：R737.9[医药卫生—肿瘤]